Search Results

The Lythos Digital Impression System in an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

The Lythos Digital Impression System (DIS) is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos DIS is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

The Lythos DIS is a point-of-care turnkey imaging system used in the dental industry; the intra-oral wand hardware and personal computer (PC) based software form an integrated system that produces accurate, high resolution three dimensional (3D) digital images. The end result of an intra-oral patient scan is a 3D digital impression data file that accurately describes the surfaces of teeth, gingiva, and palate within a patient's oral cavity, or the surfaces of a stone model.

The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand along the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic or restorative appliance manufacturers to design and manufacture customized appliances. The Lythos DIS device is also equipped with wireless network capability for secure transfer of the 3D image data to the orthodontic or restorative appliance manufacturer.

The Lythos DIS is only used to gather the topography of the mouth and teeth, and to upload the data file (.stl) to the data cloud. The data is available to the licensed dental professional to send to a third party manufacturer. The Lythos DIS .stl data file is used in conjunction with CAD/CAM or 3D printing manufacturing processes. The proposed Lythos DIS is not used for the design, diagnosis or treatment planning of orthodontic aligners.

Based on the provided text, the Lythos Digital Impression System is an optical impression system for dental professionals. The document is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device, not necessarily to prove a new device's performance against specific acceptance criteria for AI/ML-based medical devices typically seen today.

Therefore, the information requested in the prompt, particularly related to AI/ML device performance, traditional clinical studies, and specific statistical performance metrics, is largely not present in this regulatory clearance document for a digital impression system. This device is a hardware/software system that captures 3D dental impressions, not an AI/ML algorithm for diagnosis or treatment planning.

However, I can extract information relevant to the device's "performance" in terms of its ability to capture accurate impressions, as well as the types of studies performed to demonstrate its safety and substantial equivalence to a predicate device.

Here's an attempt to answer your questions based only on the provided text, with clarifications where the information is not applicable or not present.

Device Name: Lythos Digital Impression System
Type of Device: Optical Impression System for CAD/CAM in dentistry

Analysis of Acceptance Criteria and Study Proof:

Since this is not an AI/ML device in the modern sense of requiring diagnostic performance metrics (e.g., sensitivity, specificity, AUC), the concept of "acceptance criteria" for an algorithm and "study that proves the device meets the acceptance criteria" as typically understood for AI/ML devices is not directly applicable here.

Instead, acceptance criteria are aligned with demonstrating substantial equivalence to a predicate device and ensuring safety and effectiveness for its intended use, typically through non-clinical performance data (e.g., accuracy, sterilization, EMC, safety testing).

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in the format of a table with numerical targets (e.g., sensitivity > X%, specificity > Y%). Instead, it focuses on demonstrating that the Lythos DIS has "technological characteristics very similar to the predicate device" and that "accuracy testing was performed per internal methods to demonstrate substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states:

• "No human clinical data has been provided to support substantial equivalence."
• Performance data relies on "Non-Clinical Performance Data" and "Internal specification and testing for Lythos Accuracy," "Internal specification and testing for Aligner Accuracy," and "Internal specification and testing to verify use of Surface Enhancement Products."

Therefore, details like sample size for a "test set" in the context of human data (patients/cases), data provenance (country, retrospective/prospective) are not applicable as no human clinical data was used for substantial equivalence. The "test sets" would be non-human elements (e.g., dental models, materials) used for engineering and performance validation. No specific sample sizes for these internal tests are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not mentioned. Since no human clinical data was used, there were no "experts" establishing ground truth for patient cases as would be required for an AI/ML diagnostic algorithm. Ground truth for accuracy would likely be established by metrology standards for 3D scanning, which is not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. No human clinical test set, so no adjudication method for human readers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is an image acquisition system, not an AI assisting human readers. No MRMC study was done, and no human-in-the-loop performance improvement with AI was assessed as there is no stated AI component in the traditional sense.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in spirit, for the device's functional performance. The "Accuracy testing was performed per internal methods" acts as a standalone performance assessment of the device's ability to accurately capture 3D impressions. However, this is not a diagnostic algorithm's standalone performance in the context of sensitivity/specificity. The output is a data file (.stl), which is then used by a human (dental professional) and other CAD/CAM systems.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Accuracy testing," the ground truth would typically be established by highly precise metrology equipment or reference objects with known dimensions. The document does not specify the exact methods or reference standards used for this "internal methods" accuracy testing but implies an objective measure of "accuracy."

8. The sample size for the training set

The document does not detail how the internal algorithms for 3D image processing were "trained" in the machine learning sense. The device uses "algorithms in the software process these images into a 3D image." This is likely deterministic image processing / computational geometry, not typical machine learning training. Therefore, not applicable/Not mentioned in the context of ML training data.

9. How the ground truth for the training set was established

Not applicable/Not mentioned. See point 8.

Ask a specific question about this device

Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment. Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional. The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements. There are no accessories or patient contacting components of Insignia Digicast.

The provided document describes the Insignia Digicast, a software product and service that creates digital models of patients' teeth for orthodontic diagnostics.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds for measurements). Instead, it relies on demonstrating substantial equivalence to predicate devices (OrthoCAD iQ and Lava Digital Models) through qualitative comparisons of features and mode of use, and quantitative comparisons of measurement accuracy.

   Feature/Measurement	Acceptance Criteria (Implied by Substantial Equivalence)	Insignia Digicast Performance (Reported)
   Teeth Width	Functionally equivalent to predicates	Bench tested, successfully validated
   Space	Functionally equivalent to predicates	Bench tested, successfully validated
   T-J Moyers Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Bolton Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Arch Measurements	Functionally equivalent to predicates	Bench tested, successfully validated
   Overbite/Overjet	Functionally equivalent to predicates	Bench tested, successfully validated
   Overall Performance	Substantially equivalent to predicate devices	Deemed substantially equivalent

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified in the provided document. The document states "data from bench testing" was used, but does not quantify the number of cases or models tested.
   • Data Provenance: Not explicitly stated. Given it's bench testing, it's likely synthetic data, cadaver models, or a collection of patient impressions, but the origin (e.g., country) is not mentioned. It is a retrospective evaluation against existing (presumably traditional) measurements.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not specified. The document indicates that bench testing was used to "evaluate the performance characteristics... compared to the predicate device." It doesn't mention expert involvement in establishing a separate ground truth for the test set beyond the comparisons made with the predicate device's established performance.

4. Adjudication Method for the Test Set:

   • Not specified. This information is typically relevant for human-reader evaluations, which did not occur for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing has not been conducted on this product."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone evaluation was performed. The "Non-Clinical Performance Data" section describes "bench testing" to evaluate the "performance characteristics of Insignia Digicast," which is an algorithm-only assessment. The software was "successfully validated to confirm the performance of the device."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the non-clinical performance evaluation was based on comparisons to the predicate device, OrthoCAD iQ, for characteristics such as teeth width, space, and various analyses (T-J Moyers, Bolton, Arch, Overbite/Overjet). This implies the predicate device's measurements served as the reference or accepted standard.

8. The sample size for the training set:

   • Not specified. The document does not provide any details regarding the training data or its size.

9. How the ground truth for the training set was established:

   • Not specified. Since no information on the training set is provided, the method for establishing its ground truth is also unknown.

Ask a specific question about this device

Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient. The Insignia Orthodontic System is compatible with the iTero scanner.

The Insignia software creates a computer model of the patient's dentition based on a stone model, iTero scan file or impression of the patient's dentition. The iTero scanner produces a digital scan of a patient's tooth data as an alternative to the physical dental impressions. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive. Insignia with iTero consists of the following components and accessories: 1) Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist. 2) Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets. 3) Patient-specific foam bracket placement jigs to affix the brackets in position. 4) Either commercially-available or patient-specific shaped traditional archwires. The device does not include the adhesive that affixes the brackets to the teeth.

The provided text describes the "Insignia with iTero" device, an orthodontic treatment planning software and appliance system. It claims substantial equivalence to two predicate devices: "Insignia (K121524)" and "Biomet 3i Using Cadent iTero Scanner (K102209)".

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a typical pass/fail format with specific thresholds. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The primary performance aspect highlighted is the accuracy of the digital impression file generated from the iTero scanner.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document only mentions "Accuracy testing of the digital impression file..." without providing the number of scans or measurements included in this testing.
• Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not specified. The document simply mentions "Accuracy testing" without detailing how the ground truth for this testing was established or if experts were involved in its determination.

4. Adjudication Method for the Test Set:

• Not specified. There's no mention of any adjudication method (e.g., 2+1, 3+1, none) for the accuracy testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The device is not presented as an AI-assisted diagnostic tool for human readers but rather as a treatment planning software and appliance system. The evaluation focused on the accuracy of the digital impression and substantial equivalence to existing devices, not on human reader improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, implicitly. The "Accuracy testing of the digital impression file generated from the iTero scanner" appears to be a standalone performance evaluation of the scanner component, which produces a digital output (algorithm only) as an alternative to physical impressions. The software then uses this digital model for treatment planning. The "Insignia software" itself also operates in a standalone manner to calculate bracket positions.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• Not explicitly defined. For the "accuracy testing of the digital impression file," the ground truth likely involved a comparison against a highly accurate reference measurement of the dentition. This could be a physical impression measured with high-precision instruments or a different, highly accurate 3D scanning method considered the gold standard. However, the document does not specify the exact nature of this ground truth.

8. The Sample Size for the Training Set:

• Not applicable/not specified. The document describes a "proprietary software that calculates the position of dental brackets" and the "iTero scanner" which produces digital scans. While these systems likely have internal algorithms that were developed and potentially "trained," the document does not discuss a training set in the context of machine learning or AI models in the modern sense. The focus is on the output accuracy of the system's components.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/not specified. As with the training set itself, the document does not provide details on how ground truth would have been established for any internal training or development of the software or scanner's algorithms.

Ask a specific question about this device

The Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.

The Digital Impression System for Orthodontic Use (DIS) is a handheld intraoral 3D imager intended for use inside the human oral cavity to digitally capture the three-dimensional topography of teeth, gingiva, and/or palate in clinical settings. It is intended to replace traditional cast impressions which are the current standard for recording dental and orthodontic features of patients undergoing orthodontic treatment. The system is intended to be used by orthodontists and orthodontic assistants in an orthodontic office environment. The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand over the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic manufacturers to design and manufacture customized orthodontic appliances.

The provided document (K122065 510(k) Summary) describes the Digital Impression System for Orthodontic Use (DIS) and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding numerical performance metrics for the device. Instead, the "acceptance criteria" are implied by the non-clinical test's conclusion of "substantial equivalence" to traditional methods (PVS impressions).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size for the "3D topographical files" comparison study. It only states that "files were created" and "compared to files derived from, digitized polyvinylsiloxane (PVS) traditional impressions."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the comparison study. The ground truth appears to be based on "digitized polyvinylsiloxane (PVS) traditional impressions," which themselves are physical impressions. How the "ground truth" was established from these PVS impressions (e.g., by expert measurement, specific metrology tools) is not detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing has not been conducted on this product." The comparison was between digital files from the DIS and digitized traditional impressions, not involving human readers comparing output from the DIS versus traditional methods.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary test described is a standalone performance assessment. The comparison was between the 3D topographical files generated solely by the Digital Impression System for Orthodontic Use (algorithm + hardware) and files derived from digitized traditional impressions. There is no mention of human interaction or interpretation as part of this comparison.

7. The Type of Ground Truth Used

The ground truth used was based on "digitized polyvinylsiloxane (PVS) traditional impressions." This implies that the PVS impressions served as the reference for accurate topographical representation of teeth, gingiva, and/or palate. It is a form of empirical ground truth based on an established, existing clinical method.

8. The Sample Size for the Training Set

The document does not mention a training set nor its sample size. This suggests the comparison was likely an evaluation of a fully developed system rather than an iterative model training and validation process often associated with machine learning.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not applicable/not provided.

Ask a specific question about this device

The Insignia Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.

The Insignia software creates a computer model of the patient's dentition based on either a stone model or impression of the patient's dentition. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive.

Insignia consists of the following components and accessories:

1. Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist.
2. Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets.
3. Patient-specific foam bracket placement jigs to affix the brackets in position.
4. Either commercially-available or patient-specific shaped traditional archwires.
   The device does not include the adhesive that affixes the brackets to the teeth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Insignia device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria (e.g., minimum accuracy percentages, error tolerances) for the Insignia software. Instead, it relies on a comparison to a predicate device and a statement of "successful validation."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any test set used to validate the software. It merely states "the Insignia software has been successfully validated." There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish a ground truth for a test set. The validation information is extremely high-level and lacks details about specific methodologies.

4. Adjudication Method for the Test Set

Since no test set with expert-established ground truth is described, there is no information provided regarding an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The document explicitly states: "Clinical testing has not been conducted on this product." The focus is on software validation and biocompatibility, not on human-in-the-loop performance or comparison to human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone study of the algorithm's performance, separate from human interaction, was done, but with very limited detail. The statement "the Insignia software has been successfully validated to confirm the performance of the device" indicates a standalone evaluation of the software. However, the specifics of this validation (e.g., metrics, methodology, dataset) are not provided in the summary.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the software validation. Given the nature of the device (treatment planning and bracket positioning), the ground truth for an ideal outcome would likely be established through engineering design specifications, simulated clinical scenarios, or potentially comparisons to historical treatment outcomes, but this is not detailed.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. As a software for treatment planning, it's possible that the "training" refers more to the development and refinement of algorithms based on orthodontic principles and mechanical models rather than traditional machine learning training data.

9. How the Ground Truth for the Training Set Was Established

The document does not describe how ground truth for a training set was established. This lack of detail is consistent with the generally high-level overview of software validation provided in the summary.

Ask a specific question about this device

The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelostic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.

Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.

The provided text describes a 510(k) Pre-market Notification for the "Hyperelastic Archwire." This notification focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data. Therefore, the information typically requested about acceptance criteria and clinical study results for software as a medical device (SaMD) or AI-powered devices is largely not applicable in this context.

Here's an analysis based on the provided text, addressing the requested points where possible, and indicating where information is not available or not relevant for this type of device submission:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As this submission relies on bench testing of physical properties, traditional "test sets" of patient data are not applicable. The bench tests would have involved specific numbers of archwire samples for each test, but these details are not disclosed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this device does not involve human interpretation of medical images or data. Ground truth here refers to the actual physical and mechanical properties measured by scientific instruments and validated methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for clinical endpoints or interpretation of ambiguous data, which is not the case for bench testing of material properties.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interact with or are assisted by the AI. The Hyperelastic Archwire is a physical orthodontic device and does not involve AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. This device does not contain an algorithm. The "performance" here refers to the physical and mechanical characteristics of the archwire itself, measured through bench tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for this device is based on objective measurements of physical and mechanical properties through standardized bench testing methods. This includes measurements of:

• Tensile characteristics (plateau, hysteresis)
• Flexure characteristics (hysteresis)
• Binding force
• Hardness
• Roughness
• Set angle
• Elastic recovery
• Fatigue life
• Biocompatibility (based on established material safety standards)
• Corrosion resistance

8. The sample size for the training set

This information is not applicable. This device is a physical product, not a software or AI model that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for this physical device.

Ask a specific question about this device

The ClearArch is indicated for use as an orthodontic archwire to aid in the movement of patient teeth during orthodontic treatment. ClearArch is intended for patients seeking esthetic orthodontic treatment; these are primarily patients being treated with ceramic or polycarbonate braces.

ClearArch is a polymer-based orthodontic archwire for maxillary and mandibular arches. The wire material 1) is more aesthetic than conventional metal wires, 2) can take different shapes, including round, rectangular and square cross-sections, 3) can be bent like TMA and 4) delivers orthodontic forces similar to nickel titanium archwires. This archwire is intended to be used during the first two phases of orthodontic treatment. Its stiffness and strength are similar to the properties of metal orthodontic archwires in order to aid in efficient tooth movement during orthodontic treatment. Therefore, orthodontists can use an esthetic archwire in lieu of a less esthetic metal version without compromising treatment mechanics.

The provided document is a 510(k) summary for the ClearArch orthodontic wire. It focuses on demonstrating substantial equivalence to a predicate device rather than describing a study with a test set, ground truth, or expert involvement in the way AI/ML device studies typically do. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical or performance study with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it describes characteristics that were evaluated for substantial equivalence.

Study that proves the device meets the acceptance criteria:

The "study" described is a bench testing comparing the ClearArch device to a predicate device (BioMers Translucent Orthodontic Wire) and biocompatibility studies. The purpose of these tests was to demonstrate substantial equivalence for regulatory approval, not to meet specific performance acceptance criteria for a novel clinical outcome in the way an AI/ML device would.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The studies were bench tests, so "sample size" would refer to the number of wire samples tested, not patient data. Data provenance (country of origin, retrospective/prospective) is not applicable to bench testing of material properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device and study. The "ground truth" for material properties like flexural strength, tensile strength, friction, water absorption, and elongation is established by calibrated laboratory equipment and standardized testing methods, not by expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies where human interpretation of data is required to establish ground truth or resolve discrepancies. Bench testing results are typically quantitative and objective.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging) where human readers interpret medical images, and is not applicable to an orthodontic archwire.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not applicable. The ClearArch is a physical medical device (an orthodontic archwire), not an algorithm or software requiring performance evaluation in a standalone mode.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the bench testing was based on objective measurements derived from standardized material testing methods and laboratory equipment. For biocompatibility, the ground truth would be established through pre-defined toxicological and biological endpoints according to relevant standards (e.g., ISO 10993).

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical medical device like an orthodontic archwire. Training sets are used in the development of AI/ML algorithms.

9. How the ground truth for the training set was established

This is not applicable as there is no training set mentioned or implied for this device.

Ask a specific question about this device

The Transitional Tooth Replacement is intended to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors.

The Temporary Tooth Replacement is comprised of dental implant screws and prosthetic components. The system is designed to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors. The system will consist of a screw and a molded pontic tooth that would be secured to the head of the screw using adhesive. The implant screw is removed once the patient reaches maturity and a permanent implant can be placed.

This document is a 510(k) summary for a medical device called "Temporary Tooth Replacement (TTR)". It describes the device, its intended use, and claims substantial equivalence to a predicate device, the Dentatus Monorail Transitional Implant (MTI).

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory submission focused on demonstrating substantial equivalence to an already marketed device, which generally relies on comparing design, materials, and intended use rather than presenting new performance data against pre-defined criteria.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the provided text.

Here is a breakdown of why the requested information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: This document explicitly states it is claiming "Substantial Equivalence" to another legally marketed device. This regulatory pathway typically involves demonstrating that the new device is as safe and effective as a predicate device, often by showing it performs similarly. It does not usually require the establishment and reporting of new, specific acceptance criteria and the results of a study designed to meet those.
2. Sample size used for the test set and the data provenance: No test data or studies are mentioned.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no ground truth establishment is described.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: This document is about a physical medical device (dental implant), not an AI/ML algorithm. Therefore, "training set" is not relevant here.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification for a traditional medical device, not an AI/ML device, and it focuses on substantial equivalence rather than presenting new performance data against acceptance criteria.

Ask a specific question about this device

The Damon 4Clear is a ceramic bracket system intended to aid in the movement of patient teeth during orthodontic treatment.

The device is a ceramic orthodontic bracket which will encompass maxillary and mandibular brackets from 2nd bicuspid to 2m bicuspid. The Damon 4Clear appliance has both aesthetic and self-ligating qualities. The Damon 4Clear is designed with 1) improved open and close functionality and increased corner radius for increased patient comfort, 2) enhanced bracket placement with placement jigs and 3) improved overall bracket performance without changing treatment mechanics, with rotation and torque control similar to other Damon metal brackets. This system is a bondable device for fixed attached orthodontics.

I'm sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (Damon 4Clear orthodontic bracket) seeking clearance from the FDA for substantial equivalence to existing legally marketed devices.

The content focuses on:

• Device Description: What the device is.
• Intended Use: What the device is for.
• Substantial Equivalence Claim: How it is similar to other devices already on the market.
• FDA Clearance Letter: Official communication from the FDA confirming clearance based on substantial equivalence.
• Indications for Use: The specific medical purposes for which the device is intended.

A 510(k) submission generally does not require extensive clinical trials or performance studies with specific acceptance criteria in the same way a Premarket Approval (PMA) would. Instead, substantial equivalence is often demonstrated through comparisons to predicate devices in terms of materials, design, intended use, and performance characteristics. While some performance testing might be conducted to support the substantial equivalence claim, the provided text does not detail any specific acceptance criteria or study results that directly address the points in your request.

Ask a specific question about this device

The TF Rotary Nickel Titanium File is a rotary endodontic file designed for use in root canal preparation.

The TF Rotary Nickel Titanium File is an engine (rotary) driven endodontic file intended for use in root canal preparation. The TF Rotary Nickel Titanium File is made from a single bar stock of nickel titanium that is machined and formed to create a single-piece file (handle, shaft and working portion).

Flutes are ground throughout the working portion, forming the cutting edges of the instrument and creating a tapered triangular cross-section. The file blank is heat annealed and the working portion is twisted to form helical cutting edges. The file is twisted instead of ground which enhances its flexibility and durability.

The TF Rotary Nickel Titanium File has a non-cuttting (passive) tip and variable helical flute angle. The single-piece unit is intended to prevent separation of the handle from the shaft/working portion.

This document is a 510(k) Summary of Safety and Effectiveness for a medical device (TF Rotary Nickel Titanium File), submitted to the FDA. It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/algorithm-driven device.

The TF Rotary Nickel Titanium File is a physical dental instrument, not an AI or algorithm-driven device. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate conventional dental instrument. The "acceptance criteria" for a device like this would typically involve mechanical and material property testing (e.g., flexibility, durability, resistance to fracture, biocompatibility), manufacturing quality controls, and performance in simulated root canals or in vivo studies to demonstrate its ability to prepare a root canal safely and effectively. However, this specific 510(k) summary does not detail the individual tests or "acceptance criteria" and their results. It broadly states that the device "functions in a manner similar to and is intended for the same use" as a legally marketed predicate device, implying that it meets similar performance standards.

Ask a specific question about this device